MUST have Prior In-house monitoring experience within PHARMA (Not just CRO/Med Device). Must have some Pharmaceutical employment background to apply

• Assist in the management of the day to day operations of clinical trials including coordination and oversight of all CRO/clinical site/vendor activities, liaison between Clinical Operations Manager and CRO, manage scopes of work/budgets/invoice payments. • Assist in the management of the Trial Master File (submit documents, reconciliation, QC, etc.). Participate in development of protocol, case report form, CRF guidelines and other study documents. • Prepare and/or review regulatory documents (e.g. ICF), contracts, requests for proposal. Ensure the training of CROs/investigators on protocol, regulatory, Eisai SOPs and data issues. • Reviews and approves monitoring reports and ensures tracking of ongoing site issues. • Onsite Monitoring may also be required • Minimum of college degree in a relevant discipline. • Bachelor's degree in relevant scientific discipline preferred. • Oncology Experience Highly Preferred • MUST have experience with data review and patient profile review.

CANDIDATES MUST HAVE MIN 3-5 years in-house in pharma company. Not just 3-5 years in CRO or onsite monitoring. We want to see associate in-house large pharma. Also, want to see experience in phase 3 global study trials in multifunctional areas

Qualifications

* 3-5 Years In-house Clinical Monitoring Experience

* Previous Pharmaceutical employment background required

Additional Information

All your information will be kept confidential according to EEO guidelines.